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Qp Requirements Eu

The European Association of QPs has therefore published a guide to good practice summarising the duties and responsibilities of QPs in the EU (11). Annex 1 to this Guide sets out the different requirements in different Member States of the Union. For veterinary medicinal products, the requirements are laid down in DIRECTIVE 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. Article 48 of Directive 2001/83 (for veterinary medicinal products, please refer to Article 52 of Directive 2001/82) requires EU Member States to ensure that every holder of a manufacturing authorisation has at least one QP. 1. Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorisation has at his disposal permanently and permanently the services of at least one person qualified in accordance with Article 49, who shall in particular be responsible for carrying out the tasks referred to in Article 51. 2. If he personally fulfils the conditions laid down in Article 49, the holder of the authorisation may himself assume the responsibility referred to in paragraph 1. However, the areas that are confusing for U.S.

sponsors are the required QP declaration and QP certification because there are no equivalent requirements in the U.S. In today`s international pharmaceutical supply chains, it is important to know the specific requirements of different markets around the world. In Europe, not a single batch of a finished pharmaceutical product can be released without QP certification. A QP reporting template published by the EMA provides a basis for demonstrating compliance with GMP requirements through the manufacture of active ingredients and the supply chain, as well as for ensuring that the manufacturer and the QP have the relevant knowledge and security of the supply chain. (4) In Part 2 of this article, the basis established here is reinforced by valuable guidance for US sponsors in the QP certification process regarding regulatory oversight of medicines, GMP audit requirements, QP checklists and marine excursion management. The legal basis for the qualified person is laid down in european Directive 2001/83/EC of 6 November 2001 on medicinal products (4). This concept of having an individually responsible for the certification and release of batches on site is a fundamental concept of European pharmaceutical legislation that offers the competent national authorities a perfect remedy in a short period of time in the event of a problem with a batch that has been certified and approved by a particular QP. For veterinary medicinal products, the requirements are laid down in European Directive 2001/82/EC (5). 1. Member States shall take all appropriate measures to ensure that, in the case of medicinal products manufactured in the Member States concerned, the qualified person referred to in Article 48, without prejudice to his relationship with the holder of the manufacturing authorisation, is responsible, within the framework of the procedures referred to in Article 52: the placing on the market has been established and controlled; (b) in the case of medicinal products from third countries, that each production batch in the Member State of importation has undergone a full qualitative analysis, a quantitative analysis of at least all active ingredients and any other tests or controls necessary to ensure the quality of the medicinal products in accordance with the requirements of the marketing authorisation.

Consignments of medicinal products which have undergone such checks in one Member State shall be exempted from the checks if they are placed on the market in another Member State, accompanied by the control reports signed by the qualified person. 2. In the case of medicinal products imported from a third country, the Community has, where appropriate, taken steps with the exporting country to ensure that the manufacturer of the medicinal product applies standards of good manufacturing practice at least equivalent to those laid down by the Community and to ensure that the checks referred to in paragraph 1, point (b) of the first subparagraph has been exported. the qualified person may be relieved of the responsibility for carrying out these checks. 3. In all cases, in particular when medicinal products are offered for sale, the qualified person shall certify in a register or equivalent document provided for that purpose that each production batch complies with the provisions of this Article; that register or document shall be kept up to date during the execution of the works and shall be made available to the officials of the competent authority for the period provided for by the legislation of the Member State concerned and, in any event, for at least five years. The following guidelines contain further requirements for the tasks to be performed by a qualified person in Europe The European Directive 2001/83/EC defines the responsibilities of QP. Article 51 of the Directive states: `.

the PQ is responsible for ensuring that each batch has been manufactured and tested in accordance with the legislation in force in the Member State where the certification is carried out in accordance with the requirements of the Marketing Authorisation (MA) of Good Manufacturing Practice (GMP). This two-part article provides the basis for the United States…